CSL’s Quality Management System consists of an independent Quality Assurance function along with a Quality Operations group that is a part of the Clinical development organisation. Together, the two groups provide the foundation for a risk-based, proactively managed Quality System across Global Clinical development that ensures regulated clinical trial activities are:
- Conducted with a high level of quality;
- Conducted according to regulatory requirements;
- Consistent with industry best practices;
These objectives are achieved through:
- Maintenance of a robust set of written standard operating procedures (SOPs) with staff adequately trained against them;
- A compliance monitoring program to ensure adherence to the SOPs and drive inspection readiness;
- A well-defined Corrective Action/Preventive Action (CAPA) management process that promotes a systematic approach to dealing with critical/major issues and enabling study teams to effectively apply real-time lessons learned;
- Execution of audits on our investigative sites, vendors, and internal processes/systems.